Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism
This trial is active, not recruiting.
|Conditions||congenital hyperinsulinism, hyperinsulinism, persistent hyperinsulinemic hypoglycemia of infancy, chi, phhi|
|Treatments||f-dopa, pet scan|
|Sponsor||Children's Hospital of Philadelphia|
|Collaborator||University of Pennsylvania|
|Start date||December 2004|
|End date||December 2008|
|Trial size||105 participants|
|Trial identifier||NCT00674440, 2004-3-3683, 802337, FD-R-003457-01|
Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery. In this study, researchers affiliated with the University of Pennsylvania will test how well a radioactive drug (called F-DOPA) can detect a form of hyperinsulinism that may be cured by surgery. Eligible participants in this study will have positron emission tomography (PET) scans with F-DOPA prior to surgery.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
The ability of FDOPA PET to identify forms of hyperinsulinism that may be cured by surgery: focal forms.
time frame: one year
Assess safety of F-DOPA PET.
time frame: one year
Male or female participants up to 18 years old.
Inclusion Criteria: - Any age, but primarily infants 0-6 months. - Children with confirmed diagnosis of congenital hyperinsulinism. Exclusion Criteria: - Cases in which surgery will not be considered by parents or guardians.
|Official title||Localization of Focal Forms of Hyperinsulinism of Infancy With 18F-labeled L-fluoro-DOPA PET Scan|
|Principal investigator||Chaitanya R. Divgi, MD|
|Description||For children with congenital hyperinsulinism (CHI), low blood sugar is caused by cells in the pancreas that release too much insulin. Some children with CHI have these cells throughout their pancreas; others have them located in specific areas of the pancreas. Children who have them located in specific areas of the pancreas may be cured with surgery. F-DOPA is a radioactive drug that may go to these very cells. F-DOPA can also be used for positron emission tomography (or PET), an imaging technique used in nuclear medicine departments. In this study, researchers will test the possibility of using PET with F-DOPA in the diagnosis of children with hyperinsulinism.|
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